Speedy Orthodontic Screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is composed of screw and head; screw is implanted in the maxilla and/or mandible, and head is used for the connection of wire. It is from 5.35-10.5mm in total length and is made of Titanium 6Al-4V alloy. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.

AI/ML Overview

This submission is a 510(k) summary for a medical device called the "Speedy Orthodontic Screw." It's a premarket notification to the FDA, demonstrating that the new device is "substantially equivalent" to an existing, legally marketed device (the predicate device). This type of submission relies on showing similarities in design, materials, and intended use, rather than conducting new clinical trials for acceptance criteria specific to AI performance. Therefore, many of the requested fields are not applicable to this type of device submission.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly stated in the provided text as separate acceptance criteria with corresponding performance metrics for an AI device. The submission is not for an AI device, but a physical medical device. The "review" section mentions "safety, performance, and product validations" and a "review of literature pertaining to the safety and biocompatibility." These are general statements of evaluation rather than specific, quantifiable acceptance criteria or performance numbers.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a physical, non-AI medical device submission. No "test set" of data in the context of AI performance analysis is mentioned. The submission relies on demonstrating substantial equivalence to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" establishment in the context of image interpretation or diagnostic accuracy for an AI device is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No "adjudication method" for interpreting data is mentioned for this physical device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device, and therefore, no MRMC study involving human readers and AI assistance would have been conducted or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. There is no mention of "ground truth" in the context of an AI device's performance. The safety and effectiveness of the device are assessed by demonstrating similarity to the predicate device and inherent material/design properties.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set or associated ground truth establishment is relevant to this device submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):

The document describes a submission based on substantial equivalence to a predicate device, not on specific clinical studies demonstrating new performance metrics against predefined acceptance criteria for an AI or novel physical device.

The "study" or justification for safety and effectiveness is presented as:

Comparison to a Predicate Device: The Speedy Orthodontic Screw is compared to the "Dual Top Anchor System Screws, Jeil Medical Corporation, K033767." The submission states that the new device has "the same device characteristics as the predicate device. Material, design and use concept is similar."
Safety and Performance Validations: The document claims the device "has been subjected to extensive safety, performance, and product validations prior to release." While "extensive" is stated, no specific details, methodologies, or results of these validations are provided in this summary.
Literature Review: "An extensive review of literature pertaining to the safety and biocompatibility of Speedy Orthodontic Screw has been conducted." Again, no specific literature or findings are detailed.
Incorporated Safeguards: The submission states that "Appropriate safeguards have been incorporated in the design of Speedy Orthodontic Screw."

In essence, the "proof" is the argument of substantial equivalence to an already legally marketed, safe, and effective device, reinforced by general statements about safety testing and literature review, rather than a detailed report of novel performance data against specific, quantifiable acceptance criteria.

Summary

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27-5 Leui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea 442-270 Tel 82 31 207-2200 Fax 82 31 207-3933

Dentium

510(k) Summary

JUN 16 2006

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: February 21, 2006

Company and Correspondent making the submission:

Company
Name	Dentium Co., Ltd.
Address	27-5 Leui-Dong, Yeongtong-Gu,Suwon-Si, Gyeonggi-Do, Korea 442-270
Phone	+82 31 207-2200
Fax	+82 31 207-3933
Contact	K. Y. Yoon

2. Device:

Proprietary Name - Speedy Orthodontic Screw Common Name -- Small bone screw Classification Name - Endosseous dental implant

3. Predicate Device:

Dual Top Anchor System Screws, Jeil Medical Corporation, K033767

1. Classifications Names & Citations: 21CFR 872.3640, DZE, Endosseous dental implant, Class2
1. Description:

1. Indication for use:
  The Speedy Orthodontic Screw is intended for use as temporary anchor for orthodontic treatment.
1. Contra-indications:
- 1. Osteoporosis

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27-5 Leui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea 442-270 | Demtiumm
Tel 82 31 207-2200 Fax 82 31 207-3933

Dentium

1. Advanced diabetes
1. Metal allergies

8. Review:

Speedy Orthodontic Screw has the same device characteristics as the predicate device. Material, design and use concept is similar.

Speedy Orthodontic Screw has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations.

An extensive review of literature pertaining to the safety and biocompatibility of Speedy Orthodontic Screw has been conducted. Appropriate safeguards have been incorporated in the design of Speedy Orthodontic Screw.

9. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentium Co., Ltd. concludes that Speedy Orthodontic Screw is safe and effective and substantially equivalent to predicate devices as described herein.

Dentium Co., Ltd. will update and include in this summary any other information 10. deemed reasonably necessary by the FDA.
END

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JUN 16 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dentium Company, Limited C/O Ms. Cathryn N. Cambria President Arkin Consulting Group 5536 Trowbridge Drive Dunwoody, Georgia 30338

Re: K060500

Trade/Device Name: Speedy Orthodontic Screw Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 12, 2006 Received: June 14, 2006

Dear Ms. Cambria:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Cambria

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clive
Shieh, Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K K060500

Device Name: Speedy Orthodontic Screw

Indication for use: The Speedy Orthodontic Screw is intended for use as temporary anchor for orthodontic treatment.

Prescription Use______________________________________________________________________________________________________________________________________________________________ OR (Per 21CFR801 Subpart D)

Over-The-Counter Use (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sween Runne

Sign-Off)

of Anasthesiology, General Hospital,

ion Control, Dental Devices

Number. Kohoszcz

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.